(a) A utilization review entity shall make any current pre-authorization requirements and restrictions readily accessible on its website and in written or electronic form upon request for covered persons, health-care providers, and others with access to the website. Information from a utilization review entity that is not an insurer, health-benefit plan, or health-service corporation shall make this information available at an electronic pre-authorization portal that is accessible in real time. Requirements shall be described in detail but also in clear, easily-understandable language. Clinical criteria shall be described in language easily understandable by a health-care provider practicing in the same clinical area.
(b) If an insurer, health-benefit plan, or health-service corporation intends either to implement a new pre-authorization requirement or restriction, or amend an existing requirement or restriction, they shall ensure that the new or amended requirement is not implemented unless their website has been updated to reflect the new or amended requirement or restriction. This shall not extend to expansion of coverage for new health-care services.
(c) (1) If an insurer, health-benefit plan, health-service corporation, or utilization review entity intends either to implement a new pre-authorization requirement or restriction, either to implement a new pre-authorization requirement or restriction, or amend an existing requirement or restriction, they shall provide covered persons who are currently authorized by the utilization review entity for coverage of the affected health-care service care service and all contracted health-care providers who provide the affected health-care service or services of written notice of the new or amended requirement or amendment no less than 60 days before the requirement or restriction is implemented. Such notice may be delivered electronically or by other means.
(2) Notwithstanding the provisions of paragraph (c)(1) of this section, if an insurer, health-benefit plan, health-service corporation, or utilization review entity changes utilization review terms, such as clinical criteria, for a health-care service, the change in utilization review terms does not apply to covered persons with an existing authorization for the health-care service, and will apply only upon re-authorization of the health-care service. An insurer, health-benefit plan, health-service corporation, or utilization review entity must provide notice to covered persons at least 6 months before any changes to utilization review terms for a health-care service, unless those changes were due to clinical guideline status changes, recalls, market withdrawals or relevant FDA published safety information.
(d) Insurers, health-benefit plans, and health-service corporations utilizing pre-authorization shall report de-identified statistics regarding pre-authorization approvals, denials, and appeals to the Delaware Health Information Network in a format and frequency, no less than twice annually, of the Delaware Health Information Network’s request. The Department may also request this data at any time. The statistics shall include, but may be expanded upon or further delineated by regulation, categories for all of the following:
(1) For denials, the aggregated reasons for denials such as medical necessity or incomplete pre-authorization submission.
(2) For appeals:
a. Practitioner specialty.
b. Medication, diagnostic test, or diagnostic procedure.
c. Indication offered.
d. Reason for underlying denial.
e. Number of denials overturned upon appeal.
(e)Utilization review; specific requirements related to adverse determinations. —
(1) When a clean pre-authorization request is submitted by a physician or representative of a physician, an insurer, health-benefit plan, health-service corporation, or utilization review entity must ensure that any adverse determination is made by a physician who meets all of the following requirements:
a. Any compensation paid to the physician is not contingent upon the outcome of the review.
b. At least 1 of the following requirements is satisfied:
1. The physician is licensed in any United States jurisdiction with appropriate training, knowledge, or experience in the same or similar specialty that typically manages or consults on the health-care service in question.
2. The physician is licensed in any United States jurisdiction, in consultation with an appropriately qualified third-party health-care provider licensed in the same or similar medical specialty as the requesting physician, or a health-care provider with experience related to the covered person’s associated condition. Any compensation paid to the consulting health-care provider may not be contingent upon the outcome of the review.
(2) An insurer, health-benefit plan, health-service corporation, or utilization review entity must ensure that all appeals of an adverse determination related to a clean pre-authorization request submitted by a physician or representative of a physician are reviewed and determined by a physician who meets all of the following requirements, in addition to the requirements set forth in paragraph (e)(1) of this section:
a. Possesses a current, unrestricted license in good standing to practice medicine in any United States jurisdiction.
b. Was not directly involved in making the adverse determination under appeal.
c. Reviews and considers all clinical aspects of the health-care service under appeal, including all medical records of the covered person submitted as part of the pre-authorization process.
(3) When a clean pre-authorization request is submitted by a health-care provider other than a physician, an adverse determination or review in an appeal from an adverse determination must be made by a health-care provider licensed in the same or similar profession as the health-care provider submitting the request for pre-authorization, or a licensed health-care provider in consultation with an appropriately qualified third-party health-care provider licensed in the same or similar medical specialty as the requesting health-care provider. Any compensation paid to the health-care provider or consulting health-care provider may not be contingent upon the outcome of the review of the clean pre-authorization request or appeal from an adverse determination.
(4) A utilization review entity must, within 15 days of the receipt of an appeal of an adverse determination, notify the covered person and health-care provider submitting the request for pre-authorization of determination on the appeal. If the utilization review entity cannot make a determination within the 15-day period because additional information, documentation, or medical records are required to complete a review of the health-care service under appeal, the utilization review entity must notify the covered person and health-care provider submitting the request for pre-authorization in writing within the 15-day period specifying the additional information, documentation, or medical records required to complete the determination on appeal and shall have 15 days from the receipt thereof to make a determination on the appeal and notify the covered person and health-care provider. The written notification required by this paragraph (e)(4) must include all of the following:
a. A summary of the findings supporting the determination made in the appeal.
b. The qualifications of any reviewer involved in making the determination in the appeal, including any license, certification, or specialty designation of any reviewer.
c. The relationship between the covered person’s diagnosis or disease being treated and the review criteria used as the basis for the determination in the appeal, including the specific basis for the determination made.
(5) An insurer, health-benefit plan, or health-service corporation must ensure that any utilization review entity used to perform utilization review complies with all of the following:
a. Performs utilization review on weekends.
b. Provides access to a medical director or other clinical decision maker Monday through Friday between the hours of 7:00 a.m. and 7:00 p.m. and during reasonable business hours Saturday through Sunday.
c. Has established procedures for the submission of appeals in writing, electronically, or by telephone.
d. Provides a minimum of 30 days from the date of an adverse determination for the submission of an appeal.